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Amiloride / hydrochlorothiazide Pregnancy and Breastfeeding Warnings

Brand names: Moduretic, Moduretic 5-50

Medically reviewed by Drugs.com. Last updated on Jul 24, 2025.

Amiloride / hydrochlorothiazide Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed.

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned.

Risk summary: No data are available on the use of this drug in pregnant patients to inform of a drug-related risk.

Animal studies have revealed decreased pup birth weight and weaning weight at doses that reduced maternal weight gain during and after gestation. Animal studies with amiloride have shown decreased pup growth and survival. There are no controlled data in human pregnancy.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Amiloride / hydrochlorothiazide Breastfeeding Warnings

Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown (amiloride); Yes (hydrochlorothiazide)
Excreted into animal milk: Yes (amiloride)

See references

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See also

References for pregnancy information

  1. (2001) "Product Information. Moduretic (amiloride-hydrochlorothiazide)." Merck & Co., Inc
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. Cerner Multum, Inc. "Australian Product Information."
  4. (2023) "Product Information. Moduretic (amiloride-hydrOCHLOROTHIAZIDe)." Aspen Pharmacare Australia Pty Ltd
  5. (2023) "Product Information. Co-amilozide (co-amilozide)." Tillomed Laboratories Ltd
  6. (2022) "Product Information. Amiloride HCl-Hydrochlorothiazide (amiloride-hydrochlorothiazide)." Teva Pharmaceuticals USA

References for breastfeeding information

  1. (2001) "Product Information. Moduretic (amiloride-hydrochlorothiazide)." Merck & Co., Inc
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. Cerner Multum, Inc. "Australian Product Information."

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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